FDA Inspection
General Meditech IncGeneral Meditech Inc – FDA Inspection, Aug 22, 2024
Record Details
This FDA Inspection record concerns General Meditech Inc, with an inspection on August 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5909e583-023d-4cab-b37b-a89c9f34365a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1248312
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of General Meditech Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2017 | Not classified | Office of Inspections and Investigations |
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